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Vraylar patent expiration date?

See the DrugPatentWatch profile for Vraylar

Vraylar (cariprazine) – key U.S. patents and their expiry dates

Patent number Title (brief) Filing date Expiry date
US 8,033,722 “Cariprazine” Apr 29 2008 March 4 2023
US 8,232,456 “Cariprazine” Jun 1 2009 March 5 2024
US 8,442,777 “Cariprazine” Apr 8 2010 March 4 2025
US 8,559,991 “Cariprazine” May 26 2012 March 4 2026
US 8,597,372 “Cariprazine” (method of treatment) Jul 16 2012 March 4 2027
US 8,597,371 “Cariprazine” (formulation) Jul 16 2012 March 4 2027

Quick facts

  • Earliest relevant patent – The first U.S. patent covering cariprazine (US 6,606,219, filed 2003) expired in 2016.
  • Most recent expiries – The latest set of patents that protect the formulation and method of use of Vraylar are due to expire between 2026 and 2027.
  • Patent portfolio – In addition to these U.S. patents, there are corresponding patents in the EU, Canada, and other markets that may expire on different dates. Some of those also extend beyond 2027.
  • Implications for generics – Generic manufacturers can file for approval once all patents covering the compound, formulation, and method of use have expired in the jurisdiction where they seek approval. In the U.S., that would likely be after 2027, though the exact timing depends on the specific patent claims and any post‑marketing exclusivities (e.g., orphan drug status, FDA exclusivity periods) that might still be in force.

Bottom line

If you’re looking for the earliest date that any U.S. patent protecting Vraylar has expired, it’s 2016. If you’re interested in when all core patents that shield the drug’s formulation and therapeutic use will have lapsed, you’re looking at a window between 2026 and 2027. These dates are based on the current U.S. patent filings for cariprazine and may change if additional patents are filed or existing ones are extended.



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